Body Fat DisorderNCT02081196
CoolSculpting of the Flank With Alternate Treatment Parameters
A study testing The Zeltiq CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- What is being tested?
- The Zeltiq CoolSculpting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Feb 2014to 27 Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Who cannot join
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
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- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
- Subject is lactating or has been lactating in the past 6 months.
- Subject has a history of hernia in the areas to be treated.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Official title: Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
Read the detailed description
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
- Conditions
- Body Fat Disorder
- Being tested
- The Zeltiq CoolSculpting System
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zeltiq CoolSculpting SystemDevice
Also called Cryolipolysis, Lipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| CoolSculpting of the Flank With Alternate Treatment Parameters | Experimental | Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated. Receives: Device: The Zeltiq CoolSculpting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Device and/or Procedure-Related Adverse Events
The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.
Measured: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.
Measured: Pre-treatment and 16 weeks post-treatment
Secondary outcomes (2)
Proportion of Pre-treatment Images Correctly Identified.
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. Reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification.
Measured: 16 weeks post-treatment
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.
Measured: 16 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start18 Feb 2014
- Primary completion27 Jun 2014
- Study completion27 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Body Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Kilmer, MD, Principal investigator, Laser and Skin Surgery Center of Northern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081196
- Sponsor's protocol ID
- ZA13-005
- Status last verified
- Sep 2020
- First submitted
- 4 Mar 2014
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter
- ClinicalTrials.gov ID
- NCT02081196
- Acronym / sponsor ID
- ZA13-005
- Conditions
- Body Fat Disorder
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2014 (actual)
- Primary completion
- 27 Jun 2014 (actual)
- Study completion
- 27 Jun 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
Detailed description
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoolSculpting of the Flank With Alternate Treatment Parameters | Experimental | Device: The Zeltiq CoolSculpting SystemEach subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
Key exclusion criteria (16 listed)
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Zeltiq CoolSculpting SystemAlso: Cryolipolysis, LipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | CoolSculpting of the Flank With Alternate Treatment Parameters |
Primary outcome
The Number of Device and/or Procedure-Related Adverse Events
Time frame: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Time frame: Pre-treatment and 16 weeks post-treatment
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.
2 secondary outcomes
Proportion of Pre-treatment Images Correctly Identified.
Time frame: 16 weeks post-treatment
Subject Satisfaction
Time frame: 16 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Kilmer, MD principal investigator
Laser and Skin Surgery Center of Northern California
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Zeltiq CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Device and/or Procedure-Related Adverse Events (time frame: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.